Effect of Symphysis Onlay Bone Graft, Injectable Platelet Rich Fibrin (I-PRF) and Xenograft on Horizontal Alveolar Ridge Augmentation in Esthetic Zone

Evaluation of the Effect of Symphysis Onlay Bone Graft, Injectable Platelet Rich Fibrin (I-PRF) and Xenograft on Horizontal Alveolar Ridge Augmentation in Esthetic Zone. A Retrospective Study

The aim of the study: was to evaluate whether mandibular symphysis Onlay autogenous bone graft mixed with Injectable PRF could offer any advantages for patients undergoing horizontal alveolar ridge widening regarding increase alveolar ridge width compared to mandibular symphysis Onlay autogenous bone graft mixed with Xenograft

Study Overview

• Status: Completed
• Conditions: Platelet Rich Fibrin; Esthetic Zone; Symphysis Onlay Bone Graft; Xenograft; Horizontal Alveolar Ridge Augmentation
• Intervention / Treatment: Other: Injectable Platelet Rich Fibrin; Other: Xenograft

Detailed Description

Alveolar bone resorption is one of complications post-extraction complications where there is a reduction in the dimensions and quality of the alveolar bone. Alveolar bone resorption is known to occur over time, but resorption in the first few months of tooth extraction is known to be very significant.

The ideal bone graft material should have osteoconductive, osteogenic, and osteoinductive properties and mechanical stability and be free from disease. Osteoconductive is a physical property of a material that provides a framework for the growth of blood vessels and osteoprogenitor cells in bone formation. Osteoinductiveness is the ability to stimulate stem cells to differentiate in mature cells through stimulation by local growth factors. Osteogenicity is the bone growth factors in bone grafts.

Growth factors from PRF such as platelet-derived growth factor (PDGF), transforming growth factor (TGF), and insulin growth factor (IGF) are known to play a significant role in healing and bone regeneration to prevent excessive alveolar resorption after tooth extraction.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12511
    • October 6 University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age from 20 to 40 years.
• Both sexes.
• Patients suffering from horizontal alveolar ridge deficiency in anterior maxilla with labio-palatal dimensions less than 4 mm.
• Patients with adequate vertical ridge height compared to the neighboring alveolar bone.
• Patients with good oral hygiene and adjacent teeth bounding the empty span (span ranged from 1 to 4 missing teeth), should have healthy periodontium, intact or properly restored.
• Patients were apparently free from any systemic disease that may affect normal healing process of bone.

Exclusion Criteria:

• Patients suffering from any systemic diseases were excluded from the study.
• Poor oral hygiene and motivation.
• General contraindications to implant surgery.
• Uncontrolled diabetes.
• Irradiation, chemotherapy, or immunosuppressive therapy over the past 5 years.
• Active periodontitis.
• Psychiatric problems.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (Symphysis Onlay bone graft with injectable platelet rich fibrin placement); Patients underwent mandibular symphysis Onlay bone graft mixed with injectable platelet rich fibrin (I-PRF) placement.	Other: Injectable Platelet Rich Fibrin; Patients underwent mandibular symphysis Onlay bone graft mixed with injectable platelet rich fibrin (I-PRF) placement.
Experimental: Group II (Symphysis Onlay bone graft mixed with Xenograft); Patients underwent mandibular symphysis Onlay bone graft mixed with Xenograft (InterOss® Anorganic Cancellous Granules).	Other: Xenograft; Patients underwent mandibular symphysis Onlay bone graft mixed with Xenograft (InterOss® Anorganic Cancellous Granules).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alveolar ridge width	Cone beam computed tomography (CBCT) was done to all patients to measure alveolar ridge width at the following intervals: pre-operative and 6 months postoperative.	6 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone density	Cone beam computed tomography (CBCT) was done to all patients to measure bone density at the following intervals: pre-operative and 6 months postoperative.	6 months postoperative

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2021
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RECO6U/20- 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No